Quality Control Technician I
About The Position
The Quality Control Technician I, with direct supervision, is responsible for ensuring that data reported to both internal and external customers is accurate and reflects the work performed. Conducts a QC review of all study generated data as applicable to the different departments throughout the BioPharma Services to assess compliance with internal and external procedures, by the required client timelines. Inspects assay worksheets for completeness with regards to Test Methods and SOP’s. Conducts an Equipment and StatLIA printout inspection, ensuring accuracy, completeness and appropriate approvals. Conducts an inspection of Ancillary documentation. Provides a determination of acceptance for assays and results. Performs maintenance of data files and performs various data handling tasks as required. Understands and follows all procedures and processes required for work performed under the appropriate regulatory body (i.e. GxP, GMP, FDA.GLP and GCP, OECD, CLIA, etc). Attends meetings and participates on teams as required. Reads, understands and maintains compliance on all training documents as required by ETQ. Checks-in and assists in scheduling projects through the QC department. Creates where applicable and conducts 10% check of transfer files that are sent to client database. Investigates discrepant data or client questions or concerns. Completes other data related tasks as assigned, based on business needs. Maintains flexibility to meet business needs, for special projects or assisting other team members/departments as needed. Provides cross-functional support to other departments as required. Adjusts work hours as needed to meet client deadlines. Adheres to site employee health and safety (EHS) requirements. Conducts all activities in a safe and efficient manner. Demonstrates and promotes the company vision. Regular attendance and punctuality. Applies GMP/GLP in all areas of responsibility, as appropriate. Performs other duties as assigned.
Requirements
- Watson LIMS experience preferred
- Experience with Pharmacokinetic, Immunogenicity, Biomarker, cell based assay execution and data review
- Ability to read, write and interpret documents such as safety rules, standard operating procedures, maintenance instructions, and procedure manuals.
- Ability to write read and interpret technical and scientific reports and correspondence.
- Ability to perform mathematical calculations such as averages, dilutions, volumes, molarity and normality.
- Ability to perform statistical analysis and interpretation of data.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited information is available.
- Ability to construct, communicate and interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Bachelor’s Degree in a science-related field from a four-year college or university; OR minimum 2 years related experience and/or training with an associates degree in a science related field
Nice To Haves
- Ability to speak effectively before customers and employees.
Responsibilities
- Conducts a QC review of all study generated data as applicable to the different departments throughout the BioPharma Services to assess compliance with internal and external procedures, by the required client timelines
- Inspects assay worksheets for completeness with regards to Test Methods and SOP’s
- Conducts an Equipment and StatLIA printout inspection, ensuring accuracy, completeness and appropriate approvals
- Conducts an inspection of Ancillary documentation
- Provides a determination of acceptance for assays and results
- Performs maintenance of data files and performs various data handling tasks as required
- Understands and follows all procedures and processes required for work performed under the appropriate regulatory body (i.e. GxP, GMP, FDA.GLP and GCP, OECD, CLIA, etc)
- Attends meetings and participates on teams as required
- Reads, understands and maintains compliance on all training documents as required by ETQ
- Checks-in and assists in scheduling projects through the QC department
- Creates where applicable and conducts 10% check of transfer files that are sent to client database
- Investigates discrepant data or client questions or concerns
- Completes other data related tasks as assigned, based on business needs
- Maintains flexibility to meet business needs, for special projects or assisting other team members/departments as needed
- Provides cross-functional support to other departments as required
- Adjusts work hours as needed to meet client deadlines
- Adheres to site employee health and safety (EHS) requirements
- Conducts all activities in a safe and efficient manner
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Performs other duties as assigned
Benefits
- comprehensive medical coverage
- dental
- vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation
- holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
